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Browse Device Recalls

74 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 74 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 74 FDA device recalls.

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DateProductReasonClassFirm
Oct 12, 2016 GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 1... Potential presence of particulate matter on the blood side of the dialyzer Class II Baxter Healthcare Corp.
Sep 28, 2016 Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum In... A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to... Class II Baxter Healthcare Corp.
Sep 28, 2016 sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum... A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to... Class II Baxter Healthcare Corp.
Sep 28, 2016 V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA S... A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Ca... Class II Baxter Healthcare Corp.
Jun 24, 2016 Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and prod... Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUA... Class II Baxter Healthcare Corp.
May 23, 2016 PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy Presence of leaks near top of the PrismaSate bags Class II Baxter Healthcare Corp.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Feb 16, 2016 Automated peritoneal dialysis (APD) cycler Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructi... Class II Baxter Healthcare Corp.
Nov 30, 2015 Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: F... Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... Class II Baxter Healthcare Corp.
Nov 30, 2015 Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.... Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... Class II Baxter Healthcare Corp.
Nov 30, 2015 Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, ... Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... Class II Baxter Healthcare Corp.
Oct 6, 2015 Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path Leakage from the inlet port of the 15L Cycler Drainage Bags. Class II Baxter Healthcare Corp.
Jun 29, 2015 Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automat... Loud operating sounds, which was unacceptable to the end users when the device was powered on. Th... Class III Baxter Healthcare Corp.
Jan 22, 2015 MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis. Product may have separating or protruding sponges Class II Baxter Healthcare Corp.
Jan 14, 2015 Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Pla... Potential for failure of the pouch packaging seal at high altitudes. Class II Baxter Healthcare Corp.
Dec 8, 2014 Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid ... Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Casse... Class II Baxter Healthcare Corp.
Oct 21, 2014 HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal... The keypad buttons on HomeChoice devices may be activated without the operator pressing them. Class II Baxter Healthcare Corp.
Oct 6, 2014 HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter'... There are additional and updated warning and cautions that are not in the Patient At-Home Guide f... Class II Baxter Healthcare Corp.
Sep 3, 2014 SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled... One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps acc... Class II Baxter Healthcare Corp.
Jun 17, 2014 Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corp... Inadequate iodine and packaging related defects. Class II Baxter Healthcare Corp.
Jun 10, 2014 EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-... If the universal ingredient (UI) in an active configuration is changed using the Configuration Ed... Class II Baxter Healthcare Corp.
Apr 24, 2014 Baxter Amia Automated PD systems are used in the treatment of adult renal fai... System error 01779 is produced when the battery cannot be charged due to specific voltage differe... Class II Baxter Healthcare Corp.
Apr 17, 2014 The Patient Control Module (PCM) is used in conjunction with a Baxter infusor... Potential for device malfunction resulting in flow when the device should not be flowing Class II Baxter Healthcare Corp.
Apr 3, 2014 AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for p... Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increase... Class II Baxter Healthcare Corp.
Feb 7, 2014 SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product U... Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volum... Class I Baxter Healthcare Corp.
Nov 8, 2013 IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syrin... Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the ... Class II Baxter Healthcare Corp.
Oct 16, 2013 The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeCho... The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that... Class II Baxter Healthcare Corp.
Oct 7, 2013 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on... In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the p... Class II Baxter Healthcare Corp.
Sep 25, 2013 Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corp... Incomplete foil seal on one lot of sterile product. Class II Baxter Healthcare Corp.
Sep 24, 2013 SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD sc... Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion ... Class II Baxter Healthcare Corp.
Sep 10, 2013 Dual Luer Lock Cap The device is intended for use as a cap for male or fem... The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging... Class II Baxter Healthcare Corp.
Sep 4, 2013 Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 ... The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinhol... Class II Baxter Healthcare Corp.
Aug 30, 2013 Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured ... Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471 Class II Baxter Healthcare Corp.
Jul 8, 2013 Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis. the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil ... Class II Baxter Healthcare Corp.
Jun 10, 2013 SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used... Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion ... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administrat... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for ... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous ... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor:... Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implement... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Multirate Infusor Devices. Indicated for the intravenous admin... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Bax... Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implement... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Intermate Infusion Pump. Indicated for the intravenous adminis... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Regional Analgesia Infusor System with Patient Control. Indica... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Intermate Infusion Pump. Indicated for the intravenous adminis... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
May 21, 2013 Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Cor... leaking pouches Class II Baxter Healthcare Corp.
May 15, 2013 Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Conta... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.